The following data is part of a premarket notification filed by Sims Deltec, Inc. with the FDA for Port-a-cath- Ii Dual-lumen Low Profile System, Port-a-cath Ii Dual Lumen Low Profile System With Introducer Set, Port-a.
| Device ID | K974471 |
| 510k Number | K974471 |
| Device Name: | PORT-A-CATH- II DUAL-LUMEN LOW PROFILE SYSTEM, PORT-A-CATH II DUAL LUMEN LOW PROFILE SYSTEM WITH INTRODUCER SET, PORT-A |
| Classification | Port & Catheter, Implanted, Subcutaneous, Intravascular |
| Applicant | SIMS DELTEC, INC. 1265 GREY FOX RD. St. Paul, MN 55112 |
| Contact | Lisa Stone |
| Correspondent | Lisa Stone SIMS DELTEC, INC. 1265 GREY FOX RD. St. Paul, MN 55112 |
| Product Code | LJT |
| CFR Regulation Number | 880.5965 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-11-26 |
| Decision Date | 1998-01-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10610586039959 | K974471 | 000 |
| 10610586039942 | K974471 | 000 |
| 10610586020735 | K974471 | 000 |
| 10610586020711 | K974471 | 000 |
| 10610586020704 | K974471 | 000 |
| 10610586020681 | K974471 | 000 |